# K173376: ASI Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Arlington Scientific, Inc. (Asi)
- Decided: Jun 14, 2018 after 227 days
- Product code: GMQ (Antigens, Nontreponemal, All)
- Device class: 2
- Regulation: 21 CFR 866.3820
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851504 (1985). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K851504: VDRL Carbon Antigen Test S900500, S900250 & S90010, Ncs Diagnostics, Inc. (1985) Summary page 4.

## Most influential descendants
- K201438: ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer (2020), 0 descendants of its own

## Indications for use
The ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer, is a qualitative nontreponemal flocculation test for the detection of reagin antibodies in human serum and plasma as a screening test for serological evidence of syphilis. All reactive RPR test samples should be further tested with a treponemal test. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution produces only a reactive or non-reactive result and does not report RPR titers for reactive samples. The ASI Automated RPR Test for Syphilis is for professional use only. The test is intended to be used for in vitro diagnostic testing. The ASI Evolution is intended to be used as a fully automated analyzer to objectively interpret the results of the ASI automated RPR test for syphilis. The ASI Evolution is designed to provide standardized test interpretation and to provide for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. The ASI Evolution analyzer, in conjunction with the ASI Automated RPR Test is intended to be used for in vitro diagnostic testing. The ASI Automated RPR Test for Syphilis for use on the ASI Evolution produces only a reactive or non-reactive result and does not report RPR titers for reactive samples.

Source page: https://510kreport.com/device/K173376
Methodology: https://510kreport.com/methodology